Drug giant Pfizer and its partner in developing the first COVID-19 vaccine that received emergency authorization in the U.S. want to allow more adolescents to receive the vaccine.
New York-based Pfizer and BioNTech SE of Germany have asked the U.S. Food and Drug Administration to expand the emergency use authorization for their vaccine to include adolescents ages 12 through 15. Back in mid-December, the two-dose shot received emergency clearance for vaccinating people ages 16 and up.
Pfizer and BioNTech said they are working closely with the FDA and regulators in other countries to get emergency or conditional authorization as quickly as possible for kids ages 12 through 15.
The companies noted in a statement that preliminary results through March 31 from late-stage testing in that age group found the vaccine safe and 100% effective in blocking infections. They said side effects were consistent with those from testing of volunteers ages 16 through 25: pain and swelling at the injection site, fatigue, headaches, fever and nausea.
All participants in the study of 12- through 15-year-old volunteers will be monitored for two years, starting after they received their second dose, to watch for any safety issues and determine how long the vaccine protects recipients.